Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210557
Company: COSETTE

Products on NDA 210557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VYLEESI (AUTOINJECTOR)	BREMELANOTIDE ACETATE	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210557

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210557Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210557Orig1s002ltr.pdf

Labels for NDA 210557

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf
06/21/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf